Infinity plunges as it halts two saridegib trials

US drug discovery firm Infinity Pharmaceuticals (Nasdaq: INFI) saw its shares plummet 20% to $11 in pre-marketing trading yesterday morning when it announced disappointing interim data from its Phase II, double-blind, randomized, placebo-controlled study of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma.

The primary endpoint of the Phase II study was progression-free survival. While the final analysis is not complete, a planned futility analysis of data from the study was conducted by the study’s independent Data Monitoring Committee and concluded that treatment with saridegib was similar to placebo and, therefore, the trial would not meet its primary endpoint. Based on this interim analysis, Infinity is voluntarily stopping the trial. The company expects to present the final data after all analyses are complete.

Infinity also announced that it will not continue its Phase II exploratory trial of saridegib in patients with myelofibrosis. This decision was made based on data from the initial cohort of 12 evaluable patients. The level of clinical activity observed in this cohort did not satisfy the company’s pre-specified criteria for expansion.